NCT00734721已完成2 期
Fear of Intravitreal Injection - Assessment of Psychological Strain and Potential Contributing Factors
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective parameters of stress reaction
研究概览
简要总结
- Intravitreal injection can induce perioperative stress for the patients.
- Different factors can modulate the pre-operative fear and physiologic reaction.
详细描述
The aim of the study is to assess the influence of perioperative factors on objective outcome measures, which indicate the physiologic stress reaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First intravitreal injection received ever
排除标准
- •No known affective or mental disorder
- •Condition does not allow standardized survey
研究组 & 干预措施
A
Active Comparator
Presentation of factual information video
干预措施: Preoperative information and perioperative care (Behavioral)
B
Active Comparator
Presentation of injection syringe/needle
干预措施: Preoperative information and perioperative care (Behavioral)
C
Active Comparator
Presentation of emotional information video
干预措施: Preoperative information and perioperative care (Behavioral)
D
Active Comparator
Stress relaxation music
干预措施: Preoperative information and perioperative care (Behavioral)
结局指标
主要结局
Objective parameters of stress reaction
时间窗: 12 months
次要结局
- Subjective Response (state-trate anxiety) in respect of coping behaviour(12 months)
研究者
研究点 (1)
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